Senior Quality Control Manager
vor 4 Wochen
With a rich history spanning over 120 years and a dedicated workforce of more than 17,000 employees across 20 countries, Daiichi Sankyo is committed to pioneering, developing, and delivering new standards of care that enhance the quality of life globally.
Our Focus in Europe:
Our Specialty Business aims to safeguard individuals from cardiovascular diseases, which remain the leading cause of mortality in Europe, while also assisting patients in cherishing every moment of life. In the realm of Oncology, we aspire to be a global pharmaceutical innovator, crafting novel therapies for cancer patients.
Our European headquarters are located in Munich, Germany, with affiliates in 13 European nations and Canada.
Position Overview:
For Daiichi Sankyo Europe GmbH, we are in search of highly qualified candidates for the role of:
Senior Quality Manager CMO (m/f/x)Drug Product Manufacturing
The primary purpose of this role is to serve as the main point of contact for all quality-related matters at contract manufacturing organizations (CMOs).
Key Responsibilities:
- Oversee quality management at CMOs, ensuring compliance with quality standards.
- Address quality-related issues such as change control, deviations, and complaints regarding DS products at CMOs.
- Collaborate with CMOs to define effective CAPAs and monitor their timely execution.
- Independently review, assess, and approve critical documents such as APQRs, PPQ reports, and CPVs.
- Prepare and negotiate Quality Assurance Agreements (QAAs) with CMOs, ensuring adherence to DS QA standards.
- Support the establishment of new manufacturing processes and site transfers, acting as a quality subject matter expert.
- Assist CMOs during regulatory inspections and conduct audits on behalf of DS as required.
- Identify quality risks at CMOs and escalate issues when necessary.
Global Collaboration:
In this role, you will support global teams and subject matter experts in identifying and defining quality requirements for CMOs. You will disseminate quality-related information from CMOs to our global stakeholders within the QA environment and participate in cross-departmental meetings.
Continuous Improvement:
As a subject matter expert in global working teams, you will contribute to enhancing the DS quality system and global SOP framework. Sharing knowledge and expertise within QA and other functions will be essential to improving CMO management at DS.
Qualifications:
- University/FH/Master degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a related field.
- A minimum of five years of relevant experience in the pharmaceutical industry, including:
- At least two years in Quality Assurance and/or Quality Management, preferably in Shop Floor QA activities or as QA Oversight for Manufacturing Activities for Sterile Manufacturing.
- At least two years in a GxP environment within a Fill & Finish manufacturing department for sterile solutions and/or lyophilisates.
- In-depth knowledge of international GMP/GDP regulations.
- Expertise in parenteral biological manufacturing, particularly in sterile medicinal products or biological active substances.
- Strong communication skills with a diplomatic approach during negotiations.
- A collaborative team player with a high quality consciousness and a solution-oriented mindset.
- Proficient written and verbal communication skills in English and German.
- Experience managing CMOs or external suppliers is advantageous.
- Project management skills are a plus.
- Willingness to travel (up to 10%, both domestic and international).
Why Join Us?
Working at Daiichi Sankyo is more than just a job; it is an opportunity to make a meaningful impact on patients' lives. We believe that achieving our ambitious goals requires a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the chance to grow, think innovatively, and contribute your ideas.
If you possess a proactive mindset and a passion for addressing patient needs, we look forward to your application.
For more information:
www.daiichi-sankyo.eu
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